DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 11-20 have been cancelled pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/5/25.
Applicant’s election without traverse of Group I in the reply filed on 11/5/25 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 7, 8, 9, 10, 23 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keren et al. US 2021/0137507.
Regarding claim 1, Keren et al. discloses a device for closing off a left atrial appendage (LAA) of a patient (paragraph 0002), the device comprising: a proximal hub (for example, 302, 402, figures 3A, 4A, Examiner notes the proximal or distal ends may be considered either end of the closure device depending on how it is positioned); one or more fronds extending distally from the proximal hub (fronds 304, figure 3A; fronds 412, figure 4A); one or more anchors disposed at the distal end of the one or more fronds (anchors 306, figure 3A, anchors 413, figure 4A), the one or more anchors configured to engage an ostium of the LAA (paragraph 0192, anchors fasten into tissue within the LAA); and a collar disposed around the one or more fronds (collar 320, figure 3D; collar 420, figure 4B), the collar configured to move distally along the one or more fronds causing the one or more anchors to be pulled toward a central longitudinal axis into a closed position and close the ostium of the LAA (collar move distally shown in figures 3B to 3D; or figures 4D to 4F, paragraphs 0104, 0193, 0204).
Regarding claim 7, Keren et al. discloses wherein the one or more fronds comprise at least two fronds or at least four fronds (figure 3B shows 12 fronds 304).
Regarding claim 8, Keren et al. discloses wherein the collar 320 comprises a notch configured to secure the collar to a delivery device (paragraph 0196, notch cutouts 323 of locking aperture 322 to provide securement a deployment member for delivery system 110 and deployment member).
Regarding claim 9, Keren et al. discloses wherein the proximal hub 420 comprises a pin (trunk portion 411, figure 4B) configured to be disposed proximal to the collar (figure 4F, when collar has moved distally, portion adjacent hub 402 is proximal to the collar), and move distally into a central lumen of the collar (movable along central lumen 421, figure 4C), causing one or more of the fronds to be deployed, figures 4D-4F, moved from the open to closed position for grasping the tissue).
Regarding claim 10, Keren et al. discloses wherein the pin comprises a step configured to prevent the pin from extending beyond the collar (where pin attached to the collar 420, will prevent collar from moving past as the pins 411 are extended within aperture 421and will be stopped when reaches the full cylindrical hub portion, see annotated figure 4A below).
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Regarding claim 23, Keren et al. discloses wherein the distal end of the one or more fronds are curved into the one or more anchors (figure 3B, distal ends bend at portion 306).
Regarding claim 25, Keren et al. discloses wherein the system comprises a device for closing off a left atrial appendage (LAA) of a patient (paragraph 0002), the device comprising: a proximal hub (for example, 302, 402, figures 3A, 4A); one or more fronds extending distally from the proximal hub (fronds 304, figure 3A; fronds 412, figure 4A); one or more anchors disposed at the distal end of the one or more fronds (anchors 306, figure 3A, anchors 413, figure 4A), the one or more anchors configured to engage an ostium of the LAA (paragraph 0192, anchors fasten into tissue within the LAA); and a collar disposed around the one or more fronds (collar 320, figure 3D; collar 420, figure 4B), the collar configured to move distally along the one or more fronds causing the one or more anchors to be pulled toward a central longitudinal axis into a closed position and close the ostium of the LAA (collar move distally shown in figures 3B to 3D; or figures 4D to 4F, paragraphs 0104, 0193, 0204), and a delivery system configured to deliver the delivery device (for example, figure 4D)
Claim(s) 1-5, 7, 9, 22, 24, 25 and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sibbitt, JR. et al. US 2007/0060895.
Regarding claim 1, Sibbitt, JR. et al. discloses a device for closing off a left atrial appendage (LAA) of a patient (tissue closure device is configured to close off a LAA if placed within the LAA as the device may close vascular punctures or other openings, paragraph 0008), the device comprising: a proximal hub (for example, 103, 303, figures 1(b)), 3(b)); one or more fronds 101 or 301 extending distally from the proximal hub (figures 1(b), 3(b)); one or more anchors 102 or 302 disposed at a distal end of the one or more fronds (figure 1(a), 3(a)), the one or more anchors configured to engage an ostium of the LAA (paragraph 0027, 0031, anchors 302 are tissue engagement structures, configured to engage an ostium of the LAA); and a collar 105 or 305 disposed around the one or more fronds (figure 1a(b), 3(b)), the collar configured to move distally along the one or more fronds causing the one or more anchors to be pulled toward a central longitudinal axis into a closed position and close the ostium of the LAA (figures 3(a) to figures 1(b), 3(b) collar 105 or 305 moves distally along fronds 101, 301 resulting in the fronds being pulled together).
Regarding claim 2, Sibbitt, JR. et al. discloses wherein the collar is configured to lock the one or more fronds in the closed position (locking retainer 305, closed position for example, figure 3(b); retaining locking device prevents the structure from reopening, paragraph 0045).
Regarding claims 3 and 4, Sibbitt, JR. et al. discloses wherein the one or more fronds comprise a first bump feature (for example, fronds may be straight as shown in the figures, or may be curved or have a wave structure or other design, paragraph 0027), wherein the collar is further configured to move distally along the one or more fronds and over the first bump feature, and wherein the first bump feature is configured to retain the collar in a distal position relative to the first bump feature (paragraph 0027, may comprise a curved or wave structure designed to engage a retaining lock or collar, Examiner notes the collar is configured to move over the fronds as it is moved distally, the wave shapes may be considered a configuration to retain the collar, as the collar may be designed to engage the curves or wave shape).
Regarding claim 5, Sibbitt, JR. et al. discloses wherein the one or more fronds comprise a second bump feature disposed distally from the first bump feature (fronds may be straight as shown in the figures, or may be curved or have a wave structure or other design, paragraph 0027; Examiner notes a wave structure will comprise at least two bumps or bend portions).
Regarding claim 7, Sibbitt et al. discloses wherein the one or more fronds comprise at least two fronds or at least four fronds (for example, figure 1(a) discloses 8 fronds).
Regarding claim 9, Sibbitt et al. discloses wherein the proximal hub comprises a pin (for example, 303 columnar lumen which may be considered a pin) configured to be disposed proximal to the collar (figure 3(b)) and move distally into a central lumen of the collar, causing the one or more fronds to be deployed (moving pin 303 distally through collar would allow for the fronds to expand, or be deployed).
Regarding claim 22, Sibbitt et al. discloses wherein the one or more fronds 301 extend from the pin 303 (for example, figure 3(b)).
Regarding claim 24, Sibbitt et al. discloses wherein the pin is configured to move proximally such that the one or more fronds are retracted (for example, fronds are connected to pin 303, therefore moving the pin 303 proximally will also retract fronds proximally).
Regarding claim 25, Sibbitt, JR. et al. discloses a device comprising: a device for closing off a left atrial appendage (clips, for example, 100, 300, 400, paragraph 0133), comprising a proximal hub (for example, 103, 303, figures 1(b)), 3(b)); one or more fronds 101 or 301 extending distally from the proximal hub (figures 1(b), 3(b)); one or more anchors 102 or 302 disposed at a distal end of the one or more fronds (figure 1(a), 3(a)), the one or more anchors configured to engage an ostium of the LAA (paragraph 0027, 0031, anchors 302 are tissue engagement structures, configured to engage an ostium of the LAA); and a collar 105 or 305 disposed around the one or more fronds (figure 1a(b), 3(b)), the collar configured to move distally along the one or more fronds causing the one or more anchors to be pulled toward a central longitudinal axis into a closed position and close the ostium of the LAA (figures 3(a) to figures 1(b), 3(b) collar 105 or 305 moves distally along fronds 101, 301 resulting in the fronds being pulled together) and a delivery system configured to deliver the device, the delivery system comprising a tube configured to be removably coupled to the device (figures 1A-1E; 4D-4F, overtube tube 111 with deployment tube 112; or deployment member 415, paragraph 0205 releasing deployment member).
Regarding claim 26, Sibbitt, JR. et al. discloses wherein the tube comprises an outer tube (for example figure 1E, overtube 111), wherein the delivery system further comprises an inner tube (catheter tube 112, figure 1E) configured to be positioned within the outer tube and removably coupled with the device (figure 1E).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Keren et al. US 2021/0137507 in view of Sibbitt, JR. et al. US 2007/0060895.
Regarding claim 6, Keren et al. discloses the device essentially as claimed as discussed above, wherein the collar is further configured to: move distally along the one or more fronds and over the first bump feature causing the one or more fronds to be pulled a first distance toward the central longitudinal axis and into a partially closed position (for example, collapsed configuration between figures 3A, open and closed figure 3D); moving the collar distally along the one or more fronds causing the front to be pulled a second distance toward the central longitudinal axis (various shapes to the arms may allow for a first and second bump feature, the device will provide at least two collapsed or fully collapsed configurations or pulled a first and second distance toward the central longitudinal axis (between the open and closed configurations, for example, figure 3A-3D, 4D-4F), but fails to explicitly disclose moving the collar distally along the one or more fronds and over the second bump feature causing the one or more fronds to be pulled the second distance toward the central longitudinal axis and into the closed position.
Sibbitt, JR. et al. discloses wherein the collar is further configured to: move distally along the one or more fronds and over the first bump feature causing the one or more fronds to be pulled a first distance toward the central longitudinal axis and into a partially closed position (for example, figure 1(b) (paragraph 0027, may comprise a curved or wave structure designed to engage a retaining lock or collar, Examiner notes the collar is configured to move over the fronds as it is moved distally, the wave shapes may be considered a configuration to retain the collar, as the collar may be designed to engage the curves or wave shape); but fails to explicitly disclose moving the collar distally along over the second bump feature causing the one or more fronds to be pulled a second distance toward the central longitudinal axis and into the closed position.
Examiner notes Keren et al. discloses moving a collar distally to move the fronds to a collapsed or pulled a first and second distance toward the longitudinal axis. Sibbitt, JR. et al. discloses the fronds may be a straight, curved or wave configuration the shape may engage with the locking collar.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the fronds of Keren et al. to comprise a wave configuration, the wave configuration resulting in at least a first and second bump feature to form a wave structure, as taught by Sibbith, JR. et al. since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Examiner notes the combination would result in the claimed structure, as the collar is configured to move along the fronds distally, the fronds being a wave configuration to move the fronds to a partially and then fully closed configuration.
Claim(s) 21, 28, 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Keren et al. US 2021/0137507 in view of Callaghan et al. US 2006/0122647.
Regarding claims 21, 28, 29 and 30, Keren et al. discloses wherein the delivery system comprises a deployment member 415 comprising protrusions for interlocking with a portion of the proximal hub or pin (paragraph 0203) to engage a radial notch 410 of the collar of the device (figure 4E, paragraph 0203, may protrude into the apertures 410), but fails to explicitly disclose pincer arms configured to engage a radial notch of the collar of the device, the notch disposed around radially around a perimeter of the collar, or a push rod configured to engage a pin of the device, the push rod configured to advance the pin to deploy the one or more fronds from an undeployed configuration.
Callaghan et al. discloses a closure device 310 comprising a delivery system configured to delivery the device (figure 21), the delivery system comprising a tube 356 (figure 21) configured to removably couple the device (figures 28 and 29), the delivery system comprising pincers arms 346 configured to removably engaged a radial notch 314 extending radially around a perimeter of the collar of the device (figure 28), a push rod configured to engage a pin of the device (for example, 332), the push rod comprising a thread on a distal end (delivery wire 380, figure 23, female threaded portion, paragraph 0102), the thread of the pushrod configured to removably couple with a thread of the pin (paragraph 0102, pin threaded component 332), and configured to advance the pin to deploy the one or more fronds from an undeployed configuration (for example, pin engages with corresponding threads, paragraph 0102, undeployed configuration for example, figure 22 within tube to deploy the fronds when advanced, figures 28, 29).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Keren et al. with pincer arms to engage a radial notch or a push rod configured to advance the pin to deploy the one or more fronds from an undeployed configuration, as taught by Callaghan et al. as a known substitution in the art for a deployment system having protrusions for engaging and maintaining a collar of a device during delivery and deployment of the fronds while being deployed from an outer tube at the desired deployment location.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Keren et al. US 2021/0137507 in view of Rafiee et al. US 2020/0383668.
Regarding claim 27, Keren et al. discloses a system for closing a LAA of a patient, as discussed above, but fails to further disclose a tether configured to connect a pin of the device to the wall of the LAA.
Rafiee et al. discloses a system for closing a LAA of a patient comprising an occluder (paragraph 0020), further comprising a tether configured to connect a pin of the device to a wall of the LAA (occluder may further comprise a length limiting tether that connects to a first coupling, or a pin, of the occluder and configured to couple to a distal anchor, for example, figure 14B), the tether may apply tension to draw the occluder and connect with an external anchor to allow for a length limiting member or tether (paragraphs 0020-0023).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a tether configured to connect to a pin or hub of the device, as taught by Rafiee et al. to provide a tether connecting the occluder device or pin with an external anchor, the tether allowing for tension and length adjustment therebetween as necessary securing the occluder and anchor within the LAA.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/
Examiner, Art Unit 3771